Justice Scalia’s majority opinion, written for himself, Chief Justice Roberts, and justices Thomas and Alito, would have arguably swept away nearly a half century of Medicaid law and hold that lawsuits could not be brought by providers in federal court to enforce the requirements of the Medicaid program. A dissenting opinion, written by Justice Sotomayor for herself and Justices Kennedy, Kagan, and Ginsburg would have held that providers could have a cause of action under some circumstances to enforce the Medicaid law’s provider payment requirements against the states. Justice Breyer, the deciding vote for the majority, wrote a narrow opinion, joining Justice Scalia’s opinion only in part, leaving the law somewhat unsettled as to rights under the Medicaid program going forward.]]>While all eyes in the health policy community have been fixed on the Supreme Court, awaiting its decision in King v. Burwell regarding the legality of premium tax credits granted through the federally facilitated marketplaces, a case of arguably equal importance has been quietly awaiting a decision. On March 31, 2015, a closely divided Supreme Court decided in Armstrong v. Exceptional Child Center, Inc. that health care providers cannot sue state Medicaid programs in federal court to enforce 42 U. S. C. §1396a(a)(30)(A) which requires states to “assure that payments are consistent with efficiency, economy, and quality of care” while “safeguard[ing] against unnecessary utilization of . . .care and services.”

Justice Scalia’s majority opinion, written for himself, Chief Justice Roberts, and justices Thomas and Alito, would have arguably swept away nearly a half century of Medicaid law and hold that lawsuits could not be brought by providers in federal court to enforce the requirements of the Medicaid program. A dissenting opinion, written by Justice Sotomayor for herself and Justices Kennedy, Kagan, and Ginsburg would have held that providers could have a cause of action under some circumstances to enforce the Medicaid law’s provider payment requirements against the states. Justice Breyer, the deciding vote for the majority, wrote a narrow opinion, joining Justice Scalia’s opinion only in part, leaving the law somewhat unsettled as to rights under the Medicaid program going forward.

The case was brought by providers of habilitation services challenging the payment rates for these services under the Idaho Medicaid program under subsection (30)(A). The Ninth Circuit found that Idaho’s Medicaid program had conducted studies to determine appropriate rates and had recommended significant increases in rates. The Idaho legislature had failed to appropriate the funds for these increases and the Medicaid program thus denied the rate increases. The court found that Idaho’s action violated (30)(A), affirming a lower court decision that enjoined the state from basing its rates on “purely budgetary reasons.” The court enjoined the state rates under the Supremacy Clause of the Constitution, which provides that state laws that violate federal law are unconstitutional. The Supreme Court granted certiorari and reversed.

Justice Scalia’s Opinion

Justice Scalia begins by asserting that “the Supremacy Clause is not the ‘source of any federal rights’” and “certainly does not create a cause of action.” He finds no evidence in the preratification debates on the Constitution that the drafters intended the Supremacy Clause in itself to create a right in individuals to sue to enforce federal law. Scalia argues that the Constitution gave Congress the responsibility to decide under what circumstances private individuals can enforce federal law. All members of the Court agree with Scalia that the Supremacy Clause does not itself create a federal right to sue in federal court.

Scalia proceeds to acknowledge that the courts have long recognized that federal law preempts state law when it is properly raised in cases before the court, as when criminal defendants are charged under state law for conduct that federal law requires, or when businesses are subjected to state laws that are preempted by federal law. Federal courts as courts of equity may enjoin illegal actions by state officials, but this is not because the Supremacy Clause creates a cause of action, but rather because courts have inherent equitable authority to block illegal executive action. Again, the entire Court is with him this far.

Justice Scalia, however, turns next to the question of whether the providers can sue in equity to enforce the Medicaid law. While recognizing that courts can enforce federal law against state officials in equity, Scalia opines that this enforcement authority is not available under (30)(A). First, he argues that the Medicaid statute allows the federal government to withhold funds from the states for failure to comply with federal law, suggesting that Congress meant to preclude private lawsuits to enforce the law. The Court held over four decades ago that the theoretical authority of HHS to withhold funds from the states in Social Security Act cases does not preclude private enforcement; indeed Justice Scalia recognized this himself in a 2011 case. As the dissent points out, withholding funds cannot be an adequate remedy for violations of the Medicaid law, as the primary victims of this remedy would be the beneficiaries of the program whom it is intended to help.

Scalia proceeds, however, to offer a second reason why the Court should not intervene in this case—the complexity of the “judgment-laden” decision that must be made under (30)(A) as to whether provider rates are “consistent with efficiency, economy, and quality of care.” Scalia concludes that Congress intended to delegate this determination exclusively to HHS, taking advantage of the agency’s expertise and ability to achieve uniformity of application.

Scalia next turns to another contention by the dissent: Although the Supremacy Clause does not explicitly create a private cause of action and Congress can displace the equitable authority of the Court, the presumption should be that the Court has equitable power to deal with state violations of federal law unless Congress expressly limits that authority because the Court has long exercised that authority without disapproval by Congress. Scalia rejects this argument as to (30)(A), which he believes expressly limits the Court’s authority. Subsection (30)(A) was adopted by Congress as a successor to the Boren Amendment, which the Supreme Court decided could be enforced by providers under 42 U.S.C. § 1983 in Wilder v. Virginia Hospital Association; however, Scalia says this does not indicate that Congress intended to create a private right of action under (30)(A), since the law on the enforceability of the Boren Amendment was unsettled at the time Congress adopted the present version of (30)(A).

Section 1983 is a Civil War era civil rights law which the Court has long held gives private individuals the right to enforce against state officials rights protected by federal law. Medicaid beneficiaries have long been able to sue states for violation of federal Medicaid law under section 1983, and Wilder allowed providers to sue under section 1983 as well. Rights under section 1983 have been steadily narrowed by the Court in recent years. Scalia continues this course, arguing in a footnote that Wilder may no longer be good law given subsequent Court decisions under 1983.

Finally, in part IV of this opinion, which Justice Breyer did not join and which thus does not speak for a majority of the Court, Justice Scalia questions whether providers have any federal rights under the Medicaid law. He opines that Spending Clause legislation, like the Medicaid program, “is much in the nature of a contract” between the federal and state government and that third party beneficiaries to that contract cannot enforce it unless their rights are “unambiguously conferred.” Scalia expresses doubts that providers are intended beneficiaries of the Medicaid program, and thus whether they have any rights at all. He leaves open the question of to what extent Medicaid recipients are intended beneficiaries, but also states that “the modern jurisprudence permitting intended beneficiaries to sue does not generally apply to contracts between a private party and the government, much less to contracts between two governments.”

Decades of Supreme Court decisions have recognized the rights of beneficiaries of Social Security Act programs, including Medicaid, to sue to enforce rights under those programs, and Wilder, again, recognized those rights in providers as well. Part IV of the decision suggests that Scalia is not done with restricting those rights.

Justice Breyer’s Opinion

Although Justice Breyer joins the majority in much of its decision, his opinion is much narrower. Breyer recognizes that the federal courts can in certain instances issue injunctions against state officials for violating federal law. He further opines that there is no simple formula for determining which federal laws can be enforced in this way and which cannot. He concludes, however, that (30)(A) is a statute that cannot be enforced in this way.

Breyer sees (30)(A) as a rate-setting statute—indeed, a statute that governs rates paid to 1.36 million doctors serving 69 million patients in 50 states. The task of reviewing rates is appropriately left to administrative agencies. Courts can review their decisions, but are not suited for engaging in direct rate setting, which is what Breyer believes the courts are being asked to do here. Breyer suggests that other remedies might be appropriate, including withholding funds from the states, but also perhaps a lawsuit by HHS against a state or perhaps an Administrative Procedure Act action against HHS in egregious cases.

Justice Sotomayor’s Opinion

Justice Sotomayor’s opinion in dissent contends that the Court has restrained state actions contrary to federal law since the early days of the Republic. She cites a long list of federal cases recognizing this fact. She agrees that the Supremacy Clause itself does not create a private cause of action, but contends that this does not mean, as Scalia noted, that the court cannot enjoin at equity state violations of the law.

Moreover, she argues, Congress has long accepted the authority of the courts to enforce federal law. This authority exists independent of 42 U.S.C. § 1983, which has more limited application because it grants broader remedies, including suits for damages. Suits for injunctions to enforce federal law are permitted unless expressly or implicitly barred by Congress.

Justice Sotomayor concludes that Congress has not implicitly barred a Supremacy Clause suit to enforce (30)(A). First, as the Court has recognized before, the authority of HHS to withhold federal Medicaid funds is not an adequate alternative remedy. Providers have no way of initiating such an action. Moreover, withholding federal funds would directly harm those whom the law was intended to help, and is thus not an adequate remedy. Second, the fact that (30)(A) establishes broad standards for evaluating the adequacy of Medicaid rates does not prove that Congress intended it to not be enforced judicially. In fact, at the time Congress adopted (30)(A) in its present form, most courts had held that the Boren Amendment, which preceded it, was judicially enforceable, but Congress did not explicitly reject judicial enforcement.

Justice Sotomayor recognizes that the broad language of (30)(A) counsels giving the state substantial leeway and granting appropriate deference to HHS when it approves a state’s rate methodology. In appropriate cases, a court could also call on HHS for its opinion as to a particular payment scheme, and in any event a court should exercise its discretion in deciding whether or not to grant relief, as courts do in equity cases. In a long footnote, Justice Sotomayor opines that the Ninth Circuit opinion may not have been correct on the merits, but chides Justice Breyer for confusing the question of whether the decision was right on the merits with whether a court can review a state’s rates at all. In conclusion, she observes again that the remedy of withholding federal funds is no remedy at all, and that it cannot be concluded that Congress meant to substitute this non-remedy for at least the possibility of enforcement of federal Medicaid law by the federal courts.

Looking Forward

This is a momentous decision. Justice Scalia’s opinion, were it supported by a clear majority, could have largely eliminated decades of court decisions allowing the federal courts to enforce the Medicaid law. Justice Breyer’s concurrence muddies the waters a bit. Although Breyer’s opinion could suggest greater reliance by the courts on HHS to enforce Medicaid rights in the future, he leaves open the possibility of judicial enforcement of Medicaid rights where they are clearer, and preserving existing enforcement rights under 42 U.S.C. § 1983.

It remains to be seen, however, how the lower courts and future Supreme Court decisions will interpret this decision: whether they will limit it to the situation it in fact addressed—an attempt by Medicaid providers to seek judicial interpretation of a broad and vague statutory provision—or whether they will see it as an attempt to much more sharply limit the rights of Medicaid beneficiaries and providers to any redress for violation of the federal Medicaid law.

]]>http://healthaffairs.org/blog/2015/03/31/supreme-court-turns-back-payment-suit-by-medicaid-providers/feed/0Growth And Dispersion Of Accountable Care Organizations In 2015http://healthaffairs.org/blog/2015/03/31/growth-and-dispersion-of-accountable-care-organizations-in-2015-2/
http://healthaffairs.org/blog/2015/03/31/growth-and-dispersion-of-accountable-care-organizations-in-2015-2/#commentsTue, 31 Mar 2015 13:00:57 +0000http://healthaffairs.org/blog/?p=4582989 provider organizations joined the Medicare Shared Savings Program (MSSP) as accountable care organizations (ACOs). While this year’s new entrants are a smaller cohort than those that joined in 2013 and 2014, they represent a continuation of the expansion of the accountable care movement. The recent Department of Health and Human Services (HHS) announcement of its goal to move fifty percent of Medicare payments to alternative payment models (including ACO-based arrangements) indicates the government’s strong backing of the model and, coupled with continuing endorsement of the approach from state Medicaid programs and commercial insurers, there is strong support for this care delivery approach to continue.

In an ACO, health care providers accept responsibility for the cost and quality of care for a defined population. Each ACO’s laudable goal is to achieve what Don Berwick has called the “triple aim” -- to improve quality, increase patient satisfaction, and lower costs. The key to reaching those goals is to change how providers are paid, based on reaching certain cost and quality benchmarks. In effect, the objective is to change incentives so that it is in providers’ best interest to maximize health, rather than focus on increasing the volume of services rendered.]]>In January, an additional 89 provider organizations joined the Medicare Shared Savings Program (MSSP) as accountable care organizations (ACOs). While this year’s new entrants are a smaller cohort than those that joined in 2013 and 2014, they represent a continuation of the expansion of the accountable care movement.

The recent Department of Health and Human Services (HHS) announcement of its goal to move 50 percent of Medicare payments to alternative payment models (including ACO-based arrangements) indicates the government’s strong backing of the model and, coupled with continuing endorsement of the approach from state Medicaid programs and commercial insurers, there is strong support for this care delivery approach to continue.

In an ACO, health care providers accept responsibility for the cost and quality of care for a defined population. Each ACO’s laudable goal is to achieve what Don Berwick has called the “triple aim” — to improve quality, increase patient satisfaction, and lower costs. The key to reaching those goals is to change how providers are paid, based on reaching certain cost and quality benchmarks. In effect, the objective is to change incentives so that it is in providers’ best interest to maximize health, rather than focus on increasing the volume of services rendered.

ACO Growth

Leavitt Partners has been actively tracking ACOs since 2010, maintaining a database that is updated regularly from publicly available information and personal and industry interviews. Over the past year, approximately 120 organizations have become ACOs in public and private programs, bringing the total to 744 since 2011 (Figure 1). The historical ACO growth data shown in Figure 1 are slightly different from our past estimates, as they are now based on the start date of the ACO’s contract, not on when the ACO was announced.

For example, the 89 ACOs announced in December 2014 are listed as beginning in January 2015, which is the start of their contract. Regardless of how many contracts an ACO is engaged in, both public and private, an ACO is counted only once. Note that some of the new Medicare Shared Savings Program participants already had commercial contracts, and are thus tracked beginning at the start of their first contract.

Figure 1. Total Public and Private Accountable Care Organizations, 2011 to January 2015

Source: Leavitt Partners Center for Accountable Care Intelligence

In addition to growth in the total number of ACOs, there has been continued growth in the number of people covered by ACO arrangements. Since the start of 2014, an estimated 4.5 million more people have been included in accountable care arrangements, bringing the total to 23.5 million covered ACO lives (Figure 2). Of these, only 7.8 million are part of the Medicare ACO programs (Pioneer and Medicare Shared Savings Program), meaning that the majority of ACO volume is coming from the commercial and Medicaid sectors.

Figure 2. Number of ACO Covered Lives, 2011 to January 2015

Source: Leavitt Partners Center for Accountable Care Intelligence

ACO Dispersion

The geographic distribution of ACOs has continued to expand as ACOs have begun to form in more markets and to expand within markets. Accountable care organizations exist in all 50 states, Washington, D.C., and Puerto Rico, with the number of ACOs strongly correlated with the population (rs=.895, p<.001). California has the most ACOs with 81, followed by Florida with 66 and Texas with 48.

When evaluating ACOs at the Hospital Referral Region (HRR) level, there is still a strong correlation between ACO prevalence and population, though the relationship is not as strong (rs=.645, p<.001). ACOs now exist in 272 of the 306 HRRs and Puerto Rico. Figures 3 and 4 show counts of ACOs by state and by Hospital Referral Region, respectively. It is important to note that there are still many regions of the country where there is negligible ACO activity.

Figure 3. Number of ACOs by State, January 2015

Source: Leavitt Partners Center for Accountable Care Intelligence

Figure 4. Number of ACOs by Hospital Referral Region, January 2015

Source: Leavitt Partners Center for Accountable Care Intelligence

Looking at the market penetration of ACOs is a different story, as high population centers may have high numbers of ACOs, but relatively low total penetration of ACO enrollment as a percentage of state population. Figures 5 and 6 show the estimated percent of the entire population within a state or Hospital Referral Region that is covered by an ACO. Market penetration is highest in markets where there are multiple providers participating in ACOs, such as in Oregon, which has moved its Medicaid population into accountable care programs, or in regions where a dominant provider has become an ACO.

Figure 5. Estimated Percent of Population Covered by an ACO, by State, January 2015

Source: Leavitt Partners Center for Accountable Care Intelligence

Figure 6. Estimated Percent of Population Covered by an ACO, by Hospital Referral Region, January 2015

Source: Leavitt Partners Center for Accountable Care Intelligence

Growth In The Number Of ACO Contracts

The growth in the total number of ACOs and the number of covered lives only tells part of the story. Organizations that have found success with a pilot program are well-positioned to expand their patient population, and recently, ACOs have increasingly expanded the number of contracts under which they are operating. For example, in 2011, 85 percent of ACO contracts were the organization’s first contract. By 2014, only 59 percent of the contracts were first contracts (Figure 7). As of January 2015, 26 percent (192/744) of ACOs had more than one accountable care contract, and 10 percent (73/744) had three or more contracts. Overall, there are 1,046 known contracts for 744 ACOs.

Figure 7. New Accountable Care Contracts by Year

Source: Leavitt Partners Center for Accountable Care Intelligence

Payer Involvement

The involvement of different payers has also continued to increase over the past year. Through January 2015, 132 different payers have entered into at least one accountable care contract, an increase of 26 since the end of 2013 (Figure 8). These include Medicare, over a dozen state Medicaid plans, regional insurers, all of the large, national carriers, and some large, self-insured employers. Commercial payers—most notably Cigna, UnitedHealth, and Aetna—have significantly expanded their involvement in ACOs, with promise of more to come in 2015.

Figure 8. Number of Payers Participating in Accountable Care, 2011 to January 2015

Source: Leavitt Partners Center for Accountable Care Intelligence

Things To Watch In 2015

The accountable care movement has grown steadily over the past few years. However, 2015 will be pivotal as to whether the ACO model will move from a series of exploratory programs toward mainstream adoption across the country. During 2015, observers should pay close attention to several factors that will directly impact the overall trajectory of the movement.

Changes to the MSSP. The Medicare Shared Savings Program is nearing the end of its initial performance period and is expected to make some significant changes to the program. The proposed rules released in December 2014 suggest substantive potential changes, including modifying when providers must move toward two-sided risk and how patients are attributed to ACOs. Many commenters have aspects of the proposed changes, but the true impact will be felt only when the final rules are released and subsequently implemented in the next agreement period.

A requirement that forces ACOs to bear two-sided risk before they feel prepared could lead to a mass exodus from the voluntary program. Such a result would discourage providers currently considering joining the program and could significantly stymie the progress of government-backed ACOs. The proposed rules, though, suggest that CMS may be more flexible with this requirement and allow continued participation with one-sided-only risk, which may keep existing participants in the program and continue to entice new enrollees.

In addition to changes to the Medicare Shared Savings Program, the newest initiative from the Center for Medicare & Medicaid Innovation, the Next Generation ACO Model, suggests how the Medicare ACO models may evolve. The Next Generation model allows providers to assume higher levels of financial risk for greater rewards than are available under the current Pioneer and MSSP models, with the possibility of eventually accepting capitated payments. With Medicare offering multiple programs, organizations that are prepared to increase financial risk may do so through the Next Generation Model, but those that are still learning can continue participation in the lower-risk MSSP.

The HHS Goal. The Department of Health and Human Services has set a goal of moving 50 percent of payments toward alternative models by 2018, creating the potential to significantly accelerate the movement. Even with government action, though, the transition toward accountable care will not be immediate, as providers continue to experiment with different approaches to managing the health of populations and learn what works in practice within their unique organizations. The 2018 goal is ambitious, but whether it is reached will largely depend on the details of the program. A particular challenge will be to jumpstart growth in regions of the country that have yet to see any interest from providers in participating in accountable care arrangements.

Expansion of Medicaid ACOs. Medicaid ACOs have grown significantly over the past year, and 16 states have now passed ACO legislation or have enacted ACO-like pilot programs. These states, including Alabama, Vermont, Oregon, and New Jersey, represent a variety of different approaches — ranging from capitated payments to payments closely mimicking the MSSP. Because of the large size of Medicaid programs and states’ ability to mandate payment models, states can accelerate the regional growth of ACOs if and when they decide to move toward accountable care.

Organizational Infrastructure is Key to Success. Much of the policy conversation around accountable care has focused on payment models. While it is certain that payment models do incent behavior, adopting a payment model does not guarantee that a provider will be able to transform the practice of care in a way that improves outcomes and lowers cost. Organizational transformation is always difficult, and health care transformation is no exception.

A myopic policy focus on payment ignores the core objective of accountable care, which is to improve the delivery of care, not simply change how providers are paid. Only if successful care delivery models are identified, shared, and made replicable for a broad variety of provider types will ACOs succeed. Public and private payers who are experimenting with ACOs need to identify pathways to success that reflect the variety of providers that are engaging in accountable care and recognize that there is no single approach that will work for all ACOs.

Predicted ACO Growth

Predicting the future of ACO growth is an inexact science that depends on countless factors (including those described above), ranging from government action to future technological innovation to the early success of specific organizations. Recognizing this uncertainty, many people still wonder what the future growth of ACOs may entail. Figure 9 illustrates our “best guess” projection of the future growth of accountable care over the next five years. We predict that ACOs will cover over 70 million people by the beginning of 2020, and more than 150 million people in 2025. Worst-case scenario models see ACOs decreasing in size within two years, and best-case scenarios put the majority of Americans into ACOs by 2018.

Figure 9. Estimated Future Growth of Lives Covered by ACOs

Source: Author’s Analysis

Observations

In the past year, there have been an increasing number of assessments of early ACOs, covering the success of MSSP participants (cost, quality, and regional factors), individual commercial programs, and broad overviews of all ACOs. The consensus is that the outcomes are mixed, which is to be expected when so many different organizations are trying to accomplish the same goals but in very different ways.

From my work over the past year, I have come to three important takeaways regarding the ACO movement. First, it takes considerable time and managerial resources to become a full-fledged ACO. While many organizations have failed to date to fully realize all of the goals of accountable care, many have made significant progress in transforming how they deliver care. However, a full transformation cannot be realized in just a year or two. Early findings are interesting and relevant but don’t help us predict whether any particular ACO will be successful in the long term.

Second, providers in ACOs are still optimistic that they will be able to learn how to effectively care for defined populations. There are now replicable, successful models to emulate. Overall, very few organizations that have become ACOs have subsequently abandoned the model. The most public example is the Pioneer ACO Program, where 13 of 32 ACOs have chosen to leave that program, but all have either transitioned to the MSSP program or continued with another, non-Medicare ACO arrangement.

Third, the best way to manage a population differs based on structural characteristics of the provider organization. Accountable care organizations range from relatively small, primary-care physician groups to large, multi-state integrated delivery networks. Such disparate organizations have different capabilities, different needs, and different opportunities. There are many pathways that organizations can take to effectively bear risk, but shorter-term success is more likely to be achieved by focusing on maximizing what the organization has the ability to do well, as opposed to trying to develop new capacities.

]]>http://healthaffairs.org/blog/2015/03/31/growth-and-dispersion-of-accountable-care-organizations-in-2015-2/feed/0Building A Quality Of Life National Movement: Igniting Advocacy To Integrate Palliative Care In Our US Health Systemhttp://healthaffairs.org/blog/2015/03/30/building-a-quality-of-life-national-movement-igniting-advocacy-to-integrate-palliative-care-in-our-us-health-system/
http://healthaffairs.org/blog/2015/03/30/building-a-quality-of-life-national-movement-igniting-advocacy-to-integrate-palliative-care-in-our-us-health-system/#commentsMon, 30 Mar 2015 14:13:35 +0000http://healthaffairs.org/blog/?p=45922This post is part of a periodic Health Affairs Blog series on palliative care, health policy, and health reform. The series features essays adapted from and drawing on a recent volume, Meeting the Needs of Older Adults with Serious Illness: Challenges and Opportunities in the Age of Health Care Reform, in which clinicians, researchers and policy leaders address 16 key areas where real-world policy options to improve access to quality palliative care could have a substantial role in improving value.

As our health system faces dramatically rising numbers of people living longer with complex chronic conditions, we have an unprecedented opportunity to mobilize a “quality of life” movement promoting patients’ choices and priorities about how they want to live at all stages of illness. Most of the current public policies and discourse about quality of life in health care focuses on the end of life. That tradition may actually impede delivery of person-centered and goal-directed quality care from the onset of illness. It also falls short in supporting shared decision-making, which requires early and continuing identification of what is most important to seriously ill patients and their families, and what they are hoping for as they progress along the continuum of care.

All people want to live healthy and disease-free lives for as long as possible. When serious illness does strike, patients and families want to achieve, cure, or keep disease progression in check. In addition, they place a high premium on maintaining good functioning and quality of life for as long as possible so they can continue to pursue life goals and enjoy what matters most to them. They want coordination and connection, including clear communication and quality time with their health care team to help them understand treatment options and the implications of those treatments in terms of survival, functioning, and quality of life. In addition, they want support to make informed decisions during and after treatment that align with their personal preferences and goals.
]]>Editor’s note: This post is part of a periodic Health Affairs Blog series on palliative care, health policy, and health reform. The series features essays adapted from and drawing on a recent volume, Meeting the Needs of Older Adults with Serious Illness: Challenges and Opportunities in the Age of Health Care Reform, in which clinicians, researchers and policy leaders address 16 key areas where real-world policy options to improve access to quality palliative care could have a substantial role in improving value.

As our health system faces dramatically rising numbers of people living longer with complex chronic conditions, we have an unprecedented opportunity to mobilize a “quality-of-life” movement promoting patients’ choices and priorities about how they want to live at all stages of illness. Most of the current public policies and discourse about quality of life in health care focuses on the end of life. That tradition may actually impede delivery of person-centered and goal-directed quality care from the onset of illness. It also falls short in supporting shared decision-making, which requires early and continuing identification of what is most important to seriously ill patients and their families, and what they are hoping for as they progress along the continuum of care.

All people want to live healthy and disease-free lives for as long as possible. When serious illness does strike, patients and families want to achieve, cure, or keep disease progression in check. In addition, they place a high premium on maintaining good functioning and quality of life for as long as possible so they can continue to pursue life goals and enjoy what matters most to them. They want coordination and connection, including clear communication and quality time with their health care team to help them understand treatment options and the implications of those treatments in terms of survival, functioning, and quality of life. In addition, they want support to make informed decisions during and after treatment that align with their personal preferences and goals.

However, our acute “sick care” system has not yet adapted to effectively manage the needs of patients with complex chronic illness across all populations and care settings to help preserve their quality of life at every age and disease stage. Nor is it set up to adequately assess and address pain, symptoms, and distress as equal priorities of care across what can be a long trajectory of multiple care transitions and follow-up. The result is a health system that is technology- and disease-driven, but shortchanges quality-of-life considerations for nearly everyone — especially our sickest adults and children.

Our National Institutes of Health research agenda is similarly structured in disease-centric silos, with public policy proposals offering a disjointed patchwork of provisions divided by diagnosis, prognosis, and professional discipline. As a consequence, quality-of-life concerns and the person-centered communication required to identify and address them are typically treated as the stepchild of all and favorite of none, leaving many seriously ill adults, children, and their loved ones suffering from preventable pain, symptoms, and other distressing physical and emotional effects throughout their lifetime.

Several Institute of Medicine reports over the past decade have addressed cancer, palliative, psychosocial, survivorship, pain, and most recently, end-of-life care. These reports have documented our health system’s shortfalls, all reinforced poignantly through the patient stories detailed in Atul Gawande’s recent bestseller, Being Mortal, and Frontline interview. As a key part of the solution, the Institute of Medicine reports consistently call for early integration of palliative care, recognizing the importance of personal choice and person-centered, goal-directed communication as its foundation.

Palliative care is care for adults and children with serious illness that focuses on relieving suffering and improving quality of life for patients and their families, but is not intended to cure the disease itself. It provides patients of any age or disease stage with relief from symptoms, pain, and stress, and should be provided along with curative treatment. With specialist palliative teams now in place at the majority of U.S. hospitals, palliative care has hit its stride as one of the nation’s fastest growing health care trends.

Over the past decade, quality-of-life related legislation and regulation have focused primarily on pain medication and prescribing policies. Most proposals address quality of care only at the end of life (i.e., when prognosis is very poor). Such proposals include advance care planning and advance directives, physician or medical orders for life-sustaining treatment (POLST, MOLST and others), the Medicare hospice benefit, and other aspects of caring for people who are near death. These are important policies, but fail to address the quality-of-life needs that patients and families have while living with long-term chronic conditions, before they reach the end of life.

We need a new policy and advocacy platform that reflects the reality of prognostic uncertainty and people’s desire for a good life while living with, and being treated for, serious diseases of all kinds. We must respond to today’s prolonged chronic illness experience so we support all seriously ill adults and children in identifying their own quality of living formula during and after treatment and in the weeks, years, or decades they have ahead. Those documented and accessible quality-of-life goals can then guide informed treatment decisions, shared-decision-making, long term complex chronic care management, and advanced care planning preferences as patients approach the end of life.

Innovative online decision support tools such as PREPARE already exist to guide people in having these quality-of-life conversations from the onset. As highlighted in the Quality Cancer Care and Dying in America consensus recommendations, improving health professional communications skills is also a priority area for action. Tools to support goal-directed clinical communication skills development for practitioners are available through VITALtalk™, the Clinical Communication Collaborative, The Center to Advance Palliative Care, and the End-of-Life Nursing Consortium (ELNEC).

To propel palliative care into the limelight as a key strategy for improving quality of life, the American Cancer Society has partnered with its advocacy affiliate, the American Cancer Society Cancer Action Network (ACS CAN), and multiple other stakeholders in a coordinated campaign featuring research grant support, information and outreach, and legislation. This national campaign emphasizes the importance of “treating the person beyond the disease.” The Cancer Action Network’s annual How Do You Measure Up report provides specific recommendations and updates for improving the state-by-state pain and palliative care policy landscape, offering a handy reference tool all stakeholders can use to coordinate advocacy action.

High quality health care must protect quality of life and prevent suffering for all adults and children confronting serious illness during disease-directed treatment and its aftermath. With more people living longer with complex chronic conditions, prolonging survival time alone is not enough. Our system must also address quality-of-life concerns concurrently so all seriously ill individuals—at any age and any disease stage—are supported to survive and thrive. Now is the time for all professionals and policymakers to engage alongside patients and caregivers as a force for change in this national quality-of-life movement. The seriously ill adults, children, and families we all strive to serve deserve nothing less.

]]>http://healthaffairs.org/blog/2015/03/30/building-a-quality-of-life-national-movement-igniting-advocacy-to-integrate-palliative-care-in-our-us-health-system/feed/1The Time Is Now To Fix Medicare ACOshttp://healthaffairs.org/blog/2015/03/27/the-time-is-now-to-fix-medicare-acos/
http://healthaffairs.org/blog/2015/03/27/the-time-is-now-to-fix-medicare-acos/#commentsFri, 27 Mar 2015 17:14:47 +0000http://healthaffairs.org/blog/?p=45654th, the Department of Health And Human Services established national Medicare pay-for-value goals. By 2016, the Department intends to tie 30 percent of Medicare payments, and by 2018 50 percent of payments, to quality or value through alternative payment models. Medicare Accountable Care Organizations (ACOs) are expected to make a significant contribution toward meeting these goals. With current ACOs accounting for 7.8 million beneficiaries and 15 percent of Medicare spending, it will be essential for the current 405 ACOs to stay in the Medicare Shared Savings Program (MSSP) through 2016, and for a substantial number of new ACOs to join the program.

However, common concerns about the MSSP became apparent a year ago when stakeholders submitted comment letters in response to the Centers for Medicare and Medicaid Services’ "Evolution of ACO Initiatives at CMS" RFI (Request for Information). These concerns were reinforced last July after CMS announced proposed changes to ACO quality measure set and quality performance benchmarking, and again in November when the National Association of ACOs reported survey data showing nearly two-thirds of member ACOs would leave the program unless substantial improvements were made.

Recognizing these concerns, this past December CMS published a proposed rule offering many possible improvements to the Shared Savings Program. Public comments were due February 6th. CMS now has the opportunity to use stakeholder input to redesign the program in a way that will allow ACO providers to drive payment and delivery reform and thereby enable DHHS to meet its newly established pay-for-value goals.]]>This past January 20th, the Department of Health And Human Services established national Medicare pay-for-value goals. By 2016, the Department intends to tie 30 percent of Medicare payments, and by 2018 50 percent of payments, to quality or value through alternative payment models. Medicare Accountable Care Organizations (ACOs) are expected to make a significant contribution toward meeting these goals. With current ACOs accounting for 7.8 million beneficiaries and 15 percent of Medicare spending, it will be essential for the current 405 ACOs to stay in the Medicare Shared Savings Program (MSSP) through 2016, and for a substantial number of new ACOs to join the program.

However, common concerns about the MSSP became apparent a year ago when stakeholders submitted comment letters in response to the Centers for Medicare and Medicaid Services’ “Evolution of ACO Initiatives at CMS” RFI (Request for Information). These concerns were reinforced last July after CMS announced proposed changes to ACO quality measure set and quality performance benchmarking, and again in November when the National Association of ACOs reported survey data showing nearly two-thirds of member ACOs would leave the program unless substantial improvements were made.

Recognizing these concerns, this past December CMS published a proposed rule offering many possible improvements to the Shared Savings Program. Public comments were due February 6th. CMS now has the opportunity to use stakeholder input to redesign the program in a way that will allow ACO providers to drive payment and delivery reform and thereby enable DHHS to meet its newly established pay-for-value goals.

In response to the proposed rule, eighteen ACO stakeholder groups, including physician associations, hospital groups, ACO associations, and consumer representatives jointly submitted a 36-page comment letter. (Nearly all of the eighteen organizations, joined by fifteen other stakeholder groups, also signed a shorter, six-page letter that argued more thematically for substantive MSSP improvements.) While it may be surprising, if not unprecedented, for this number of major organizations to collectively produce a detailed letter, it was the result of numerous conversations between and among the groups over many months. If adopted, these changes would substantially increase MSSP provider participation and program success.

As currently conceived, the MSSP has achieved limited success. Consider the program’s first performance year (PY1) results. CMS frequently states that half of the 220 PY1 ACOs saved money. While technically true, only 52 ACOs actually received a shared-savings payment. Sixty others spent below their benchmark but did not exceed their Medical Savings Rate (MSR), the threshold minimum amount of savings that must be achieved before ACOs begin to share in additional savings.

Performance would have been worse had PY1 quality measures been scored based on actual quality performance, not simply on accurate quality reporting; had this been the case, the $315 million these 52 ACOs earned in shared savings would have been reduced by approximately 25 percent because of imperfect quality scores. Of the over 112 ACOs that spent in excess of their benchmark, 42 would have had to repay losses if they had contracted as financially at-risk Track 2 ACOs. CMMI’s recent announcement of the “Next Generation ACO” offers new opportunities for very experienced organizations to assume greater risk and reward but will do little to improve the overall success of Shared Savings Program, since it’s a five year demonstration and the agency anticipates only 15 to 20 organizations will participate.

Redesigning health care delivery in an entrenched FFS payment system almost always involves complicated clinical redesign, challenging cultural transformation, and costly information technology adoption. In fact, NAACOS and CMS both estimate each ACO will risk a minimum of $1 million per year of uncompensated costs to carryout these changes.

ACOs are the most promising market-based solution, but Medicare ACO performance has been inhibited by specific program design flaws. In our comment letter we identify numerous improvements in context of CMS’s proposed changes. Here we offer the six we believe are the most critical.

Providers Should Be Given More Time To Participate In The Limited Or No-Risk Track 1

Instead of forcing all ACOs to two-sided risk at the end of the first contract, CMS proposed to allow ACOs to continue under Track 1 for additional three-year contract terms but with certain qualifying conditions. CMS also proposed reducing an ACO’s shared savings from 50 to 40 percent during a second contract and further still in subsequent contracts.

Based on PY1 results and because nearly 99 percent of all ACOs are in Track 1, it is essential for program sustainability to extend Track One ACO contracts. Providers simply need more performance experience before moving to an at-risk MSSP track. We disagree, however, that extending Track 1 participation should be conditional and less rewarding. While Track 1 is typically defined as “no risk,” ACO providers are risking substantial start-up and ongoing operating costs. They therefore should be given more than one contract term to demonstrate achievement and recover their investment, and the savings ratio in subsequent contracts should not be reduced.

ACOs Should Be Able To Defer Annual Reconciliation To Accrue A Larger Beneficiary Population To Meet The Minimum Savings Rate (MSR)

Track 1 ACOs should, like the Pioneer ACOs, be able to defer annual reconciliation. This would improve their chances of earning shared savings since it—by summing up yearly beneficiary totals—would effectively increase their number of beneficiaries and thereby lower their MSR threshold. (An ACO’s MSR, which accounts for statistical chance, can be as high as 3.9 percent.)

Beneficiary Assignment And Retention Should Be Improved

CMS offered three proposals to improve beneficiary assignment and affinity. We support all three but with one change. We agree with the Administration’s 2016 Budget that care provided by nurse practitioners, physician assistants, and clinical nurse specialists providing primary care should be included in Step 1 beneficiary assignment. CMS should also give Medicare beneficiaries a choice to voluntarily elect to participate in an ACO. This would likely improve provider-patient affinity. Both measures would also likely reduce the considerable problem of unstable assignment or patient churn.

CMS also proposed to create a new, at-risk Track 3. This higher risk/reward track’s other distinguishing characteristic is that patients would be assigned “prospectively” to the ACO at the beginning of the year. This means at year end no new beneficiaries would be added to the ACO’s population and thereby change its performance-year benchmark. We support adding prospective assignment in Track 3 and recommend it as an option for both Track 1 and Track 2 ACOs.

We believe payment waivers ought to be approved based on whether they can help improve clinical care and outcomes. There is sufficient evidence these four waivers would do this and we recommend they be applicable to all MSSP tracks. The SNF rule dates back to the Medicare program’s inception; beyond being antiquated, it promotes unnecessary hospital stays that drive up costs and risk patient safety. The HH rule is arbitrary in part since the Medicaid program has no such home-bound requirement. Post-acute care quality can vary significantly, and evidence supports the use of telehealth services as substitute for in-person care. In addition, we recommend ACOs be able to absorb the costs of waiving certain beneficiary primary care co-pays.

As It Does In Medicare Advantage, CMS Should Reward Good Quality By ACOs As Well As Penalizing Poor Quality

With respect to quality performance, CMS should mitigate the punitive-only aspect and reward top quartile quality performance or top quartile improvement by providing an additional 10 percentage points of shared savings in each of the three tracks.

Most Substantively, CMS Should Remedy Several Flaws In How It Establishes, Updates And Resets An ACO’s Financial Benchmark

While CMS did not recommend any specific improvements in calculating ACO financial benchmarks, the agency did present five options. We support the proposal to re-weight the three benchmark years in second and subsequent benchmark years from the current 10-30-60 weighting to 33-33-33. This would mitigate the effect of punishing ACOs that increasingly spend under their benchmark and rewarding ACOs that increasingly spend above their benchmark.

To mitigate the problem of successful ACOs always having a lower benchmark under subsequent contracts, we support the proposal to add savings achieved into the reset benchmarks. As for annually updating the benchmark, we support ACO’s having an ability to choose between a national or regional adjustment.

We also support in concept the use of regional costs to reset benchmarks. More broadly, we recommend CMS make available sufficient ACO market data to allow the provider community to empirically assess the impact of using regional cost trends and regional costs for setting the benchmark.

ACOs could make a significant contribution toward HHS meeting its 2016 and 2018 Medicare pay-for-value goals. However, CMS needs to recognize the seriousness of ACO stakeholder concerns as it develops the final rule this spring. We hope the agency enacts substantial changes to the Shared Savings Program to make it a significant contributor to transforming health care delivery and outcomes for its beneficiaries.

]]>http://healthaffairs.org/blog/2015/03/27/the-time-is-now-to-fix-medicare-acos/feed/3Paying For The ‘Doc Fix’http://healthaffairs.org/blog/2015/03/26/paying-for-the-doc-fix/
http://healthaffairs.org/blog/2015/03/26/paying-for-the-doc-fix/#commentsThu, 26 Mar 2015 19:24:24 +0000http://healthaffairs.org/blog/?p=45904
Federal scorekeepers (appropriately) assess the cost of the SGR fix relative to current law, which assumes that fees will follow a trajectory defined by current policy. But as near as I can tell, few advocate for that path or believe it will occur; rather the current system will continue to require regular “patches”. Therefore, the appropriate measure of the cost of the doc fix is spending with the fix relative to spending without it. The latter includes the costs of future “patches” necessary to ensure continued operation (as well as any savings that can be achieved because of continued SGR related negotiations). Substituting this realistic alternative into the cost calculus likely substantially lowers the incremental cost of any SGR fix.]]>For years now it has become apparent that the Sustainable Growth Rate (SGR) system is not sustainable. However, fixing the SGR will require increases in budgeted costs, and so one of the major barriers to replacing the SGR is figuring out how to pay for the fix. Towards this end, it is important to understand the appropriate cost-comparison.

Federal scorekeepers (appropriately) assess the cost of the SGR fix relative to current law, which assumes that fees will follow a trajectory defined by current policy. But as near as I can tell, few advocate for that path or believe it will occur; rather the current system will continue to require regular “patches.” Therefore, the appropriate measure of the cost of the doc fix is spending with the fix relative to spending without it. The latter includes the costs of future “patches” necessary to ensure continued operation (as well as any savings that can be achieved because of continued SGR related negotiations). Substituting this realistic alternative into the cost calculus likely substantially lowers the incremental cost of any SGR fix.

It would be useful to look beyond the single dimension of costs and move to a discussion of how and whether specific elements of the fix are likely to increase value in the Medicare program relative to realistic alternatives. For example, we could debate whether the fix is too generous (a 0.5 percent fee increase does not seem overly generous to me), or contains provisions that may increase spending without generating sufficient off-setting benefits (e.g. the pay for quality provisions).

To be clear, I am not suggesting that the debate around “pay fors” is unimportant. Indeed, the SGR debate provides the opportunity to improve payment across Medicare. Yet the principles applied to payment or benefit changes shouldn’t be tied to any specific SGR budget number. For example, if the consensus is that the level of hospital payment is too high, then we should reform hospital payments. But we should be clear that the objective is to fix hospital pay and not to fix doctor pay.

Moving beyond provider payment altogether, the progressivity of Medicare financing (e.g. how much should high income beneficiaries pay) is a crucial topic to address as baby boomers swell the ranks of the Medicare-eligible. Reasonable people will have different views on this matter and now may be the time to engage in this discussion — the SGR debate could provide an opening in which this discussion could occur. But whatever one’s view is of the appropriate amount of progressivity, it should not depend on how we pay physicians.

So as the debate surrounding the SGR continues, we cannot lose sight of the main issues facing Medicare: how will we finance the program for the baby boomers and beyond? Will we charge beneficiaries more, and if so, what role will means testing play? Are we willing to continue financing medical innovation (that has historically increased spending and on average improved quality)? Can we generate efficiencies through payment reform or other policies that reduce spending growth and relieve some of the anticipated fiscal pressure? If so, what will those policies mean for access and quality of care?

Debate over the SGR replacement should be guided by the bigger question of whether the bill moves the payment system in a desirable direction, rather than getting hung up on a cost comparison that does not reflect the appropriate concept of cost for the purposes of decision making. The correct cost comparison should be the path of spending under the proposed fix relative to a realistic path of spending under current law (including patches and their pay fors).

We are holding a poetry contest from March 25 to April 22, looking for well-crafted poems that touch on topics related to health and health policy. Three winning poems will be announced at the end of April. Winners will receive a $500 prize, publication in Health Affairs, and two copies of the issue containing the winning poem.]]>April is National Poetry Month and in celebration the Narrative Matters section of Health Affairs is seeking poetry submissions for upcoming issues of the journal.

We are holding a poetry contest from March 26 to April 22, looking for well-crafted poems that touch on topics related to health and health policy. Three winning poems will be announced at the end of April. Winners will receive a $500 prize, publication in Health Affairs, and two copies of the issue containing the winning poem.

All entries will be read by Health Affairs staff and winning poems will be selected by three guest judges:

Hakim Bellamy, a W.K. Kellogg Foundation Fellow and the inaugural poet laureate of Albuquerque, New Mexico;

Serena Fox, an intensive care physician at Mount Sinai Beth Israel Medical Center whose poems have appeared in The Paris Review, The Journal of the American Medical Association (JAMA), and Western Humanities Review, and who is author of Night Shift; and

Natalie Lyalin, author of two books of poetry—Blood Makes Me Faint But I Go For It and Pink & Hot Pink Habitat—who teaches at Philadelphia University.

Poems must be no longer than a single-spaced page, with double spaces between stanzas (font size no smaller than 11 point). Limit 3 poems per submission. Poems must be written in English, and must be previously unpublished. Please include a cover sheet with your name, address, and brief bio. The poem itself should contain no personal identifiers.

]]>http://healthaffairs.org/blog/2015/03/26/call-for-submissions-narrative-matters-poetry-contest/feed/4Health Affairs Web First: Without CHIP, Sharply Higher Insurance Costs For Many Low-Income Familieshttp://healthaffairs.org/blog/2015/03/26/health-affairs-web-first-without-chip-sharply-higher-insurance-costs-for-many-low-income-families/
http://healthaffairs.org/blog/2015/03/26/health-affairs-web-first-without-chip-sharply-higher-insurance-costs-for-many-low-income-families/#commentsThu, 26 Mar 2015 13:30:17 +0000http://healthaffairs.org/blog/?p=45846new study, being released by Health Affairs as a Web First, and also appearing in its April issue, examines the availability and cost of dependent coverage for children through employer-sponsored plans. Such plans would be the primary pathway to affordable coverage for more than half of all children losing CHIP eligibility, insofar as access to employer-sponsored coverage through their parents can bar children from receiving Marketplace subsidies.

According to the study, 96.9 percent of enrollees in employer-sponsored plans had access to dependent coverage. The additional cost would vary -- as much as $7,252 per year for workers with one dependent child and $11,829 for those with two or more dependent children. The study also found that adding dependent coverage could cost many families more than 8.05 percent of their income, qualifying them for hardship exemptions from buying coverage.

As a result, many children once covered by CHIP would no longer be insured. This study is thought to provide the first estimates documenting variations across employers in the marginal costs to families adding children to employer-sponsored plans.]]>Funding for the Children’s Health Insurance Program (CHIP) is now set to expire after September 2015. A new study, being released by Health Affairs as a Web First, and also appearing in its April issue, examines the availability and cost of dependent coverage for children through employer-sponsored plans. Such plans would be the primary pathway to affordable coverage for more than half of all children losing CHIP eligibility, insofar as access to employer-sponsored coverage through their parents can bar children from receiving Marketplace subsidies.

According to the study, 96.9 percent of enrollees in employer-sponsored plans had access to dependent coverage. The additional cost would vary — as much as $7,252 per year for workers with one dependent child and $11,829 for those with two or more dependent children. Authors Thomas Selden, Lisa Dubay, G. Edward Miller, Jessica Vistnes, Matthew Buettgens, and Genevieve Kenney also found that adding dependent coverage could cost many families more than 8.05 percent of their income, qualifying them for hardship exemptions from buying coverage.

As a result, many children once covered by CHIP would no longer be insured. This study is thought to provide the first estimates documenting variations across employers in the marginal costs to families adding children to employer-sponsored plans.

For their analysis, the authors used the 2012 and 2013 Medical Expenditure Panel Surveys (MEPS), conducted by the Census Bureau and sponsored by the Agency for Healthcare Research and Quality (AHRQ). “The estimates presented here provide clear evidence that rollbacks in public coverage could leave many families with comparatively much more costly options for covering their children,” the authors concluded. “Understanding the number of children affected by public coverage rollbacks…will be critical to the discussion about CHIP reauthorization.”

Selden, Miller, and Vistnes are affiliated with the Agency for Healthcare Research and Quality (AHRQ); Dubay, Buettgens, and Kenney are with the Urban Institute. Dubay, Buettgens, and Kenney received funding for this study from the National Institute for Health Care Reform and the Urban Institute.

]]>http://healthaffairs.org/blog/2015/03/26/health-affairs-web-first-without-chip-sharply-higher-insurance-costs-for-many-low-income-families/feed/1Executions, Doctors, The U.S. Supreme Court, And The Breath Of Kingshttp://healthaffairs.org/blog/2015/03/26/executions-doctors-the-u-s-supreme-court-and-the-breath-of-kings/
http://healthaffairs.org/blog/2015/03/26/executions-doctors-the-u-s-supreme-court-and-the-breath-of-kings/#commentsThu, 26 Mar 2015 13:00:03 +0000http://healthaffairs.org/blog/?p=45714This post is part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015. The conference brought together leading experts to review major developments in health law over the previous year, and preview what is to come. A full agenda and links to video recordings of the panels are here.

The relationship between medicine and capital punishment has been a persistent feature of this past year in health law, both at the level of medical ethics and Supreme Court review.

Our story starts in Oklahoma, where the execution of Clayton Lockett was botched on April 28, 2014. NIH bioethicist Seema Shah described the events in question:

Oklahoma was administering a new execution protocol that used the drug midazolam, a sedative that is often used in combination with other anesthetic agents. Oklahoma had never used this drug in executions before; in fact, only a few states had experience with using the drug in lethal injection. Florida had previously used this drug in lethal injections, but with a dose five times higher than what was indicated in Oklahoma’s protocol. If the execution had gone as planned, Clayton Lockett would have first received midazolam; been declared unconscious, then received vecuronium bromide (a paralytic/neuromuscular blocking agent that would restrict his movements), and finally received potassium chloride (the drug likely to end his life). A few minutes after officially being declared unconscious, Lockett mumbled statements including the word, “Man.” He “began breathing heavily, writhing, clenching his teeth and straining to lift his head off the pillow.” Prison officials prevented the witnesses from seeing the rest of the proceedings by closing the curtains. The Department of Corrections then called off the execution and unsuccessfully tried to resuscitate Lockett, and Lockett eventually died of a heart attack more than 45 minutes after the execution began. Although a Department of Corrections official stated that Lockett’s veins “exploded,” an autopsy examination performed by a forensic pathologist hired by death row inmates appears to contradict official reports. This report concluded that even though prison officials decided to inject the drugs into Lockett’s femoral vein (which is a more difficult and risky procedure), Lockett’s surface and deep veins had “excellent integrity.” Another execution that was scheduled to occur that same night has now been stayed for six months, pending an investigation into Mr. Lockett’s execution.

On July 23, 2014, Arizona encountered a problem with the same drug in the execution of Joseph Wood, wherein the condemned inmate allegedly gasped for almost two hours before dying.

The executions have prompted two important but different kinds of responses. In this post I write about the role of medical ethics and the U.S. Supreme Court’s response.]]>Editor’s note: This post is part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015. The conference brought together leading experts to review major developments in health law over the previous year, and preview what is to come. A full agenda and links to video recordings of the panels are here.

The relationship between medicine and capital punishment has been a persistent feature of this past year in health law, both at the level of medical ethics and Supreme Court review.

Our story starts in Oklahoma, where the execution of Clayton Lockett was botched on April 28, 2014. National Institutes of Health (NIH) bioethicist Seema Shah described the events in question:

Oklahoma was administering a new execution protocol that used the drug midazolam, a sedative that is often used in combination with other anesthetic agents. Oklahoma had never used this drug in executions before; in fact, only a few states had experience with using the drug in lethal injection. Florida had previously used this drug in lethal injections, but with a dose five times higher than what was indicated in Oklahoma’s protocol.

If the execution had gone as planned, Clayton Lockett would have first received midazolam; been declared unconscious, then received vecuronium bromide (a paralytic/neuromuscular blocking agent that would restrict his movements), and finally received potassium chloride (the drug likely to end his life). A few minutes after officially being declared unconscious, Lockett mumbled statements including the word, “Man.” He “began breathing heavily, writhing, clenching his teeth and straining to lift his head off the pillow.” Prison officials prevented the witnesses from seeing the rest of the proceedings by closing the curtains.

The Department of Corrections then called off the execution and unsuccessfully tried to resuscitate Lockett, and Lockett eventually died of a heart attack more than 45 minutes after the execution began. Although a Department of Corrections official stated that Lockett’s veins “exploded,” an autopsy examination performed by a forensic pathologist hired by death row inmates appears to contradict official reports. This report concluded that even though prison officials decided to inject the drugs into Lockett’s femoral vein (which is a more difficult and risky procedure), Lockett’s surface and deep veins had “excellent integrity.” Another execution that was scheduled to occur that same night has now been stayed for six months, pending an investigation into Mr. Lockett’s execution.

On July 23, 2014, Arizona encountered a problem with the same drug in the execution of Joseph Wood, wherein the condemned inmate allegedly gasped for almost two hours before dying.

The executions have prompted two important but different kinds of responses. In this post I write about the role of medical ethics and the U.S. Supreme Court’s response.

Medical Ethics

In an opinion from 1994, dissenting from the denial of certiorari in the death penalty case of Callins v. Collins, Justice Harry Blackmun famously wrote, “From this day forward, I no longer shall tinker with the machinery of death,” and concluded that he was instead “obligated simply to concede that the death penalty experiment has failed.”

Two decades later, in May 2014, shortly after the botched Oklahoma execution, Bob Truog, Mark Rockoff, and I argued in The Journal of the American Medical Association (JAMA) that physicians should take a similar position: that they should no longer tinker with the machinery of death and avoid participation in executions altogether. Our argument received significant discussion in the media, on Rachel Maddow’s MSNBC show, and elsewhere. We hope it will prompt further changes.

In our article, we advance several reasons why physician involvement in execution is problematic. This involvement co-opts the medical profession in a problematic way: “History is replete with examples of efforts by governments to co-opt the power and status of the medical profession for state purposes that are not aligned with the goals of medicine. For example, physicians have engaged in interrogations involving torture, at least in part because the skills and knowledge of these professionals enables them to maximize the prisoner’s temporary pain and suffering while minimizing the risk of permanent disability or death.”

It also medicalizes retribution. That is, “[e]xecution is, intrinsically, the involuntary taking of the life of another human being, an act that can never be aligned with the goals of medicine. Regardless of whether execution is justified—and there are those who contend that in some circumstances capital punishment may be—it must never be perceived as a medical procedure. By playing on the imagery of a scene that is almost indistinguishable from the everyday practice of anesthesiologists when they ‘put a patient to sleep,’ there is an attempt to cover the procedure with a patina of respectability and compassion that is associated with the practice of medicine.”

In this respect (and now I am speaking only for myself not my co-authors), this is a kind of kabuki theater. It would be far better to go to what we instinctively view as more barbaric methods, for example, the firing squad, that are decidedly non-medical, if we could ensure painless death. The patina of medicine helps us avoid confrontation with the barbarism of what we are doing, killing someone against their protestation.

There is also the matter that medicine needs to live up to its own professional standards. The Code of Ethics of the American Medical Association (AMA) has for decades “specifically forbidden participation by physicians in executions” and similar “positions are held by professional societies of nurses, emergency medical technicians, and correctional health care workers.”

But these prohibitions are not being fully enforced. Again in our May 2014 JAMA article, we argue that a more effective pathway to enforce ethical standards is through the system of board certification.

“Even though board certification is not required to practice medicine, in many fields it is a de facto requirement for physicians to practice within their specialties. For example, the American Board of Anesthesiology has taken the courageous step of adopting a policy that its certified members who participate in lethal injection for capital punishment are subject to having their board certification revoked. The boards of other specialties should consider taking the same action.”

That said we note the potential for legal challenges to this approach: “Whether this approach will ultimately withstand inevitable legal challenges remains to be seen, but unless the profession is willing to stand up in defense of its own ethical principles, it will lose the authority to call itself a profession.”

Supreme Court Review

The Supreme Court has also agreed to take a look at the Oklahoma drug protocol in a case now captioned Glossip v. Gross.

Four men initially asked for a stay of execution while the Supreme Court could review the petition for certiorari to analyze their case. That stay was denied on January 15, over a written dissent authored by Justice Sotomayor joined by Justices Ginsburg, Breyer, and Kagan.

After this decision most (including this author) thought the case was over, since the denial of a stay is usually an extremely good predictor of denial of certiorari in a capital case. However, very surprisingly, certiorari was granted a week later. This probably means that one justice (whose identity we will never know) voted against the stay, only to later vote for certiorari. In the interim one of the men was put to death. In other words, the delay between the stay and granting certiorari meant that one of these four men was treated differently from the other three and he is now dead. To quote the Bard from Richard II: “Such is the breath of kings.”

Arguments in the case will now be heard on April 29, 2015, with a decision expected in June. I want to draw a contrast with my earlier medical ethics discussion because, as is often the case when medical ethics makes it to the Supreme Court, the Court has agreed to take on a much narrower legal question. Here is how the Court wrote the questions presented:

(1) Whether it is constitutionally permissible for a state to carry out an execution using a three-drug protocol where (a) there is a well-established scientific consensus that the first drug has no pain relieving properties and cannot reliably produce deep, coma-like unconsciousness, and (b) it is undisputed that there is a substantial, constitutionally unacceptable risk of pain and suffering from the administration of the second and third drugs when a prisoner is conscious;

(2) Whether the plurality stay standard of Baze v. Rees applies when states are not using a protocol substantially similar to the one that this Court considered in Baze; And

(3) Whether a prisoner must establish the availability of an alternative drug formula even if the state’s lethal-injection protocol, as properly administered, will violate the Eighth Amendment.

To help digest these questions, it is useful to go through Justice Sotomayor’s opinion dissenting from the refusal to grant a stay since it gives us a good clue about how she and the other three who joined her will approach this case.

Soon thereafter, the State adopted a new execution protocol. The protocol contains a number of procedures designed to better ensure that execution team members are able to insert properly an IV line and assess the condemned inmate’s consciousness. The protocol also provides for four alternative drug combinations that can be used for lethal injections, one of which is the same midazolam/vecuronium bromide/potassium chloride combination that was used in the Lockett execution. Whereas the prior protocol called for the injection of only 100 milligrams of midazolam, the new protocol now calls for the injection of 500 milligrams of that drug. The State has announced that it plans to use this particular drug combination in all upcoming executions.

The petitioners challenged this in court as a violation of their Eighth Amendment under Section 1983. Sotomayor characterizes what happened:

Two expert witnesses for the plaintiffs testified that although midazolam could be used to render an individual unconscious, it was not and could not be relied on as an anesthetic because the patient could likely regain consciousness if exposed to noxious stimuli — such as the injection of potassium chloride.

For that reason, the Food and Drug Administration (FDA) has not approved the drug for use as an anesthetic. One expert argued that “midazolam is subject to a “‘ceiling effect’” such that, no matter the dosage, it reaches a point of saturation and has no more effect, and at this saturation point the drug cannot keep someone unconscious.

According to these experts, this feature distinguishes midazolam—a benzodiazepine, like Valium or Xanax—from barbiturates such as pentobarbital or sodium thiopental, which are often used as the first drug in a three-drug lethal injection protocol. The State’s own expert argued to the contrary.

The district court ultimately agreed with the state and denied a preliminary injunction finding inmates to be unlikely to succeed on the merits because “The proper administration of 500 milligrams of midazolam . . . would make it a virtual certainty that any individual will be at a sufficient level of unconsciousness to resist the noxious stimuli which could occur from the application of the second and third drug.”

Therefore, the lower court found that the challengers failed to establish a likelihood of being able to show that the protocol “presents a risk that is ‘sure or very likely to cause serious illness and needless suffering.’” That is a standard from Baze v. Reese, 2008, the last major Supreme Court case on lethal injection.

According to Sotomayor’s dissent, the lower court also concluded:

That there was a ‘separate reason’ the plaintiffs had failed to establish a likelihood of success: They had not identified a “‘known and available alternative’” by which they could be executed, as the State had ‘affirmatively shown that sodium thiopental and pentobarbital, the only alternatives to which the plaintiffs ha[d] alluded, are not available to the’ State.

An aside, why a shortage? Amid intense pressure by anti-death-penalty activists, the last American drug maker to produce sodium thiopental withdrew from the market in 2011. State officials scrambled to find alternative sources in overseas markets, leading to a European Union embargo of lethal-injection drugs and raids by the U.S. Drug Enforcement Agency to seize stockpiles of sodium thiopental that had been imported without a license.

The Court of Appeals for the 10th Circuit affirmed, and that is how the case made it to the U.S. Supreme Court.

Sotomayor’s opinion argued that there were serious constitutional questions with the way Oklahoma had proceeded. Here are her key points:

The Baze opinion said that a challenger must show that the risk of severe pain is “substantial when compared to the known and available alternatives.” That, however, “pertained to an Eighth Amendment claim that the procedures employed in a particular protocol were inferior to other procedures the State assertedly should have adopted.” By contrast, “the same requirement should not necessarily extend to a claim that the planned execution will be unconstitutionally painful even if performed correctly; it would be odd if the constitutionality of being burned alive, for example, turned on a challenger’s ability to point to an available guillotine.”

Second, both lower courts alternatively held that the use of midazolam did not create a substantial risk of unnecessary pain. But in the Court’s earlier case, Baze, the Court “understood that the first drug in the three-drug cocktail—there, sodium thiopental—would work as intended.” But Sotomayor and her fellow Justices in the dissent found “the District Court’s conclusion that midazolam will in fact work as intended difficult to accept given recent experience with the use of this drug. Lockett was able to regain consciousness even after having received a dose of midazolam—confirmed by a blood test—supposedly sufficient to knock him out entirely. Likewise, in Arizona’s July 23, 2014, execution of Joseph Wood, the condemned inmate allegedly gasped for nearly two hours before dying, notwithstanding having been injected with the drug hydromorphone and 750 milligrams of midazolam — that is, 50 percent more of the drug than Oklahoma intends to use.”

She also expressed skepticism of the evidentiary findings of the district court noting scientific studies of the ceiling effect. “It is true that we give deference to the district courts. But at some point we must question their findings of fact, unless we are to abdicate our role of ensuring that no clear error has been committed. We should review such findings with added care when what is at issue is the risk of the needless infliction of severe pain.”

These points give us a pretty clear outline of what she and the Justices joining her opinion think of the case.

What is likely to happen? To use a quote often ascribed to Yogi Berra, but sometimes to Niels Bohr, among others: “It’s tough to make predictions, especially about the future.” But here goes: I think the court will strike down as unconstitutional Oklahoma’s method of execution in a narrowly written opinion, and remand the case for new fact-finding on the drug itself. I think the more interesting question is whether they get to the question of pointing to a better alternative protocol.

That is, will the state’s lethal injection protocol be evaluated on its own terms as to whether it will cause an unconstitutional amount of pain or will the challenge have to point to an alternative protocol against which it is to be judged. This is Justice Sotomayor’s point that it would be odd if the constitutionality of being burned alive, for example, turned on a challenger’s ability to point to an available guillotine. My guess is that only some of the Justices will reach that question and we won’t get a definitive resolution, but it is only a guess. We will have to wait until June to find out the answer.

]]>http://healthaffairs.org/blog/2015/03/26/executions-doctors-the-u-s-supreme-court-and-the-breath-of-kings/feed/2The Final Stage Of Meaningful Use Rules: Will EHRs Finally Pay Off?http://healthaffairs.org/blog/2015/03/25/the-final-stage-of-meaningful-use-rules-will-ehrs-finally-pay-off/
http://healthaffairs.org/blog/2015/03/25/the-final-stage-of-meaningful-use-rules-will-ehrs-finally-pay-off/#commentsWed, 25 Mar 2015 18:51:13 +0000http://healthaffairs.org/blog/?p=45839HITECH Act, which spelled out a path to a nationwide health information technology infrastructure. The goal was simple: every doctor, nurse, and hospital in America should use electronic health records -- and do it in a way that leads to better care delivered more efficiently. The Act provided $30 billion in incentives for providers and hospitals who met the criteria for “Meaningful Use”, which the Obama administration was given the authority to define. The rules were set up to be rolled out in three stages, and while the first two stages have been out for a while, the criteria for the third and final stage of Meaningful Use (MU) were finally released on March 20.

David Blumenthal, the first national coordinator under HITECH, used the analogy of the Meaningful Use program as an escalator -- with the first stage focused on just getting people on board and each stage requiring a higher level of use -- which would focus on demonstrating better care through advanced EHR use. Put more simply, the goal of the three stages was to first get providers to just start using EHRs, and then over time to get them to use the systems more frequently, more robustly, and ultimately, in ways that lead to better, more efficient care.

The new stage 3 rule reflects both the successes and the failures of the first two stages. It moves toward making the EHR market more open and competitive, and providing more choices, in ways that I think are helpful -- but possibly not helpful enough.]]>Six years ago, President Obama signed into law the HITECH Act, which spelled out a path to a nationwide health information technology infrastructure. The goal was simple: every doctor, nurse, and hospital in America should use electronic health records — and do it in a way that leads to better care delivered more efficiently. The Act provided $30 billion in incentives for providers and hospitals who met the criteria for “Meaningful Use”, which the Obama administration was given the authority to define. The rules were set up to be rolled out in three stages, and while the first two stages have been out for a while, the criteria for the third and final stage of Meaningful Use (MU) were finally released on March 20.

David Blumenthal, the first national coordinator under HITECH, used the analogy of the Meaningful Use program as an escalator — with the first stage focused on just getting people on board and each stage requiring a higher level of use — which would focus on demonstrating better care through advanced EHR use. Put more simply, the goal of the three stages was to first get providers to just start using EHRs, and then over time to get them to use the systems more frequently, more robustly, and ultimately, in ways that lead to better, more efficient care.

The new stage 3 rule reflects both the successes and the failures of the first two stages. It moves toward making the EHR market more open and competitive, and providing more choices, in ways that I think are helpful — but possibly not helpful enough.

Where We’ve Been

To understand where the Obama administration is going with stage 3 Meaningful Use, it’s important to reflect on where we’ve been and how far we have come. In 2008, the year before HITECH was passed, just 17 percent of U.S. doctors – and only 9 percent of U.S. hospitals – were using an EHR. That degree of computerization was abysmal, especially for an industry as information intensive as healthcare. None of us doubted the potential of EHRs, because the evidence was overwhelming: when done right, EHRs improved the safety, effectiveness, and efficiency of healthcare delivery. This was the motivation for launching HITECH.

The focus of the first two stages was to get doctors to purchase, adopt, and start using the systems. By those metrics, the program has been a smashing success. As of 2013, more than 50 percent of physicians and more than 60 percent of hospitals were using EHRs. That is an astounding increase in the rate of adoption – no other country in the world has wired up this many doctors and hospitals this fast. Although the 2014 data are not out yet, the rate of adoption has likely continued to tick upwards, and that’s a good thing.

But if the goal is better, more efficient care, simple EHR adoption is not enough. There is plenty of evidence that EHRs don’t, unto themselves, make care better. As I described above, the evidence suggests that when done right, EHRs could transform health care. “EHRs done right” probably means something a little different for each provider, but here’s a simple notion: EHRs should be intuitive and easy to use; they should align well with the way doctors and nurses work, fitting and augmenting work flow, providing needed information and avoiding unwanted clutter. And, it should be easy to share that data with other providers and patients.

That would be a good start – and by that definition, the EHRs out there, financed in part by your tax dollars and mine, have been a disappointment. Not awful, but a disappointment. Until we fix that, it is unlikely that EHRs will pay off as an investment for the American people.

Where The Stage 3 Rules Aim To Take Us

So how do the stage 3 rules help? In some important ways, I think. But before we get there, let’s talk about what stage 3 tries to do more broadly. If you skim through the 301 page proposed rule, you’ll find two words throughout: simplicity and flexibility. By the standards of complex federal rules, I think these terms are appropriate. There’s a real effort to both simplify the complex meaningful use process and to offer some flexibility to providers in how they meet the criteria.

There are three stages of meaningful use, each with different criteria, with different providers at different stages. The proposed rule moves everyone into a single set of meaningful use criteria by 2018, which is both long enough to let providers get on board, and short enough that the simplification is valuable. Beyond this, the proposed rule streamlines the requirements and objectives of meaningful use: The program now lays out 8 objectives and gives providers flexibility in how they meet many of the objectives. The objectives fall into four buckets: assure security, prescribe electronically, use clinical decision support, and share data with other providers and patients. Combined with the requirement to submit clinical quality measures electronically, it’s not a bad list – and consistent with what Congress wanted out of HITECH.

Opening up closed EHR systems …

The big deal in the stage 3 meaningful use rules is data flow. Here, I think federal policymakers are helping to fix the big problems with EHRs, though they could go further. The current EHR vendors have prioritized integration with legacy systems and complex, secure systems over ease of use and support for better care. That’s a problem. Most of these systems are closed, making it difficult to use 3rd party vendors to improve provider experience or share data with others. If you don’t like the Apple Maps App provided on your iPhone, you can use Google Maps. If you hate the electronic prescribing system in your EHR – good luck being able to use a third party system that plugs into it. By creating closed systems, EHR vendors hamper innovation and made EHRs unnecessarily difficult and painful to use.

However, by forcing EHRs to allow for sharing of data with patients, and by pushing EHRs to incorporate patient-generated data, the new proposed rule will begin to create leaks in these closed systems. And that’s a helpful start. As the data in the EHR begins to be able to break free, third party vendors will build better tools that engage patients in their care. Requiring EHRs to incorporate data generated by patients will push the industry towards greater standardization.

…. but not quickly enough.

While these are helpful steps, they may not be enough. If we are serious about addressing EHR’s poor usability and inability to support the kind of care we are increasingly demanding, then we need to open up the EHR systems in a more robust way. As part of certification, the Office of the National Coordinator could require that all EHRs publish their full application-program interfaces (APIs). The proposed rule begins to do that, but only as it relates to sharing information with patients. This is not enough. ONC should require that any vendor that enjoys federal subsidies for its products make its full suite of APIs widely available for third party products.

This may sound like a technical issue, but it’s a critically important one. If these APIs become widely available, third party vendors will build the tools that currently limit EHR utility and value. Hate the way your EHR does clinical documentation? Use the one just developed by a new vendor down the street. That kind of competition will make everyone better.

If you were locked into using the Apple map forever, they would have little incentive to improve it. That’s how the world works – and to improve EHRs, we need the kind of competitive pressure created by open ecosystems. Stage 3 meaningful use rules move us one step towards that goal, and that’s a good thing. But given how long the journey is between EHR adoption and better care, we could surely move faster.

Our nation has made a major investment in EHRs and the signs suggest that we have made good progress. As the government finalizes the stage 3 proposed rules, it should focus on fostering systems that are open, flexible, and usable. That’s the only way we will let doctors, nurses, and others provide the kind of care that Americans need and deserve.

]]>http://healthaffairs.org/blog/2015/03/25/the-final-stage-of-meaningful-use-rules-will-ehrs-finally-pay-off/feed/2Health Affairs Briefing: The Cost And Quality Of Cancer Carehttp://healthaffairs.org/blog/2015/03/25/health-affairs-briefing-the-cost-and-quality-of-cancer-care/
http://healthaffairs.org/blog/2015/03/25/health-affairs-briefing-the-cost-and-quality-of-cancer-care/#commentsWed, 25 Mar 2015 14:23:26 +0000http://healthaffairs.org/blog/?p=45803Health Affairs, "The Cost and Quality of Cancer Care,"includes a collection of papers on the cost and quality of cancer care.

You are invited to join us on Tuesday, April 7, 2015, at a forum featuring authors from the new issue at the National Press Club in Washington, DC. Panels will cover valuing cancer care innovation, paying for care, and quality of cancer care.

Follow live Tweets from the briefing @Health_Affairs, and join in the conversation with #HA_CancerCare.

]]>Cancer is the second leading cause of death among US adults, and cancer care now costs in excess of $125 billion each year in the United States alone. Cancer has also become the second leading cause of death worldwide, making it an increasing priority in low- and middle-income countries. The April 2015 issue of Health Affairs, “The Cost and Quality of Cancer Care,”includes a collection of papers on the cost and quality of cancer care.

You are invited to join us on Tuesday, April 7, 2015, at a forum featuring authors from the new issue at the National Press Club in Washington, DC. Panels will cover valuing cancer care innovation, paying for care, and quality of cancer care.

Stacie B. Dusetzina, Assistant Professor, Eshelman School of Pharmacy and the Gillings School of Global Public Health, University of North Carolina at Chapel Hill, on For Uninsured Cancer Patients, Outpatient Charges Can Be Costly, Putting Treatments Out Of Reach

Pierre Elias, Visiting Researcher, Division of Hospital Medicine, University of California, San Francisco, on Narrative Matters: Insensible Losses: When the Medical Community Forgets the Family

Ann Geiger, Acting Associate Director, Division of Cancer Control and Population Sciences’ Healthcare Delivery Research Program, National Cancer Institute

Cary Gross, Professor of Medicine, Yale University School of Medicine, on Older Women With Localized Breast Cancer: Costs And Survival Rates Increased Across Two Time Periods

Tomas Philipson, Daniel Levin Professor of Public Policy, Irving B. Harris School of Public Policy Studies, University of Chicago, on Quality-Adjusted Cost Of Care: A Meaningful Way To Measure Innovation Cost Growth Versus The Value Of Health Gains

Ninez A. Ponce, Professor, Department of Health Policy and Management, Fielding School of Public Health, and Associate Center Director, UCLA Center for Health Policy Research, on Early Diffusion Of Gene Expression Profiling In Breast Cancer Patients Associated With Areas Of High Income Inequality